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17d
Detection of EGFR exon 20 insertion mutations in non-small cell lung cancer: implications for consistent nomenclature in precision medicine. (PubMed, Pathology)
A total of 1,418 EGFR E20ins mutations were collected from six studies (FoundationInsights, Geneseeq Technology Inc, mobocertinib phase I/II trial, poziotinib phase II trial, sunvozertinib phase I trial, and Samsung Medical Center) and reorganised according to Human Genome Variation Society (HGVS) nomenclature. To ensure comprehensive coverage in real-world settings, it is essential to standardise the annotations for each variant, for example using the HGVS nomenclature. The accurate classification and analysis of drug responsiveness in EGFR E20ins necessitate consideration of the nomenclature, particularly with respect to the locations where the actual mutations occur.
Journal • EGFR exon 20
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EGFR (Epidermal growth factor receptor)
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Oncomine™ Dx Target Test • Droplex EGFR Mutation Test v2
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Pozenveo (poziotinib) • Exkivity (mobocertinib) • sunvozertinib (DZD9008)
6ms
Gencurix, the first digital PCR-based lung cancer companion diagnostic product, received approval to sell from the Australian Ministry of Health and Welfare (Gencurix Press Release)
"Gencurix's lung cancer companion diagnostic test (product name: Droplex EGFR Mutation Test v2) has been approved for sale in Australia...This is the second approval in Australia after endometrial cancer (POLE), and both products are the first digital PCR-based diagnostic products to be approved in Australia."
Non-US regulatory
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Droplex EGFR Mutation Test v2
7ms
Gencurix receives approval to sell 6 types of companion diagnostic products, Turkiye (Gencurix Press Release)
"Six types of Gencurix' companion diagnostic tests (Droplex) have been approved for sale in Turkiye, covering most of the Droplex test portfolio in Romania, Colombia, and Germany."
Non-US regulatory
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Droplex BRAF Mutation Test • Droplex EGFR Mutation Test v2 • Droplex KRAS Mutation Test • Droplex PIK3CA Mutation Test • Droplex POLE Mutation Test • Droplex c-Met Exon14 Skipping Test
10ms
Gencurix, lung cancer companion diagnosis approved by Thai Ministry of Food and Drug Safety… Southeast Asian market entry (Gencurix Press Release)
"Gencurix...announced on the 29th that its companion diagnostic test had received approval from the Ministry of Food and Drug Safety in Thailand. The product approved this time is 'Droplex EGFR Mutation Test v2', a liquid biopsy companion diagnostic test for lung cancer from Gencurix."
Non-US regulatory
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Droplex EGFR Mutation Test v2
10ms
Gencurix’s lung cancer companion diagnosis platform obtained UAE approval (Gencurix Press Release)
"Molecular diagnosis company Gencurix's companion diagnostic platform 'Droplex' received sales permission from the UAE Ministry of Health and Welfare on the 9th...The product approved this time is 'Droplex EGFR Mutation Test v2', a liquid biopsy companion diagnostic test for lung cancer. It can detect a total of 107 gene mutations and is characterized by improved accuracy by using highly sensitive digital gene amplification (PCR) technology."
Non-US regulatory
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Droplex EGFR Mutation Test v2
11ms
EGFR Exon 20 Insertion Mutations in NSCLC: The Need for Accurate Naming Conventions and Implications for Personalized Therapy (IASLC-WCLC 2023)
This study investigated the distribution of EGFR E20ins in the Asian population, with p.A767_V769dup and p.S768_D770dup being the most frequently observed mutations. Since some studies have reported single EGFR E20ins sequences using different names, it is important to be cautious when describing EGFR E20ins. To ensure comprehensive coverage in real-world settings, each method used for the detection of EGFR E20ins must be annotated according to the HGVS nomenclature.
EGFR exon 20
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EGFR (Epidermal growth factor receptor)
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EGFR mutation • EGFR exon 20 insertion • EGFR exon 20 mutation • EGFR A767_V769dup • EGFR S768_D770dup
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cobas® EGFR Mutation Test v2 • Oncomine™ Dx Target Test • Droplex EGFR Mutation Test v2 • GenesWell ddEGFR Mutation Test
1year
Gencurix Obtains Approval for Companion Diagnostic of Digital PCR-based EGFR Mutation Test (PRNewswire-Asia)
"Gencurix...has obtained approval from the Korean Ministry of Food and Drug Safety for its Droplex EGFR Mutation Test v2. This product is a companion diagnostic test designed to detect EGFR mutations commonly found in NSCLC patients and guide the selection of appropriate targeted anticancer therapies based on the test results....Compared to existing EGFR mutation tests using RT-PCR, this product demonstrates significantly higher sensitivity. This makes it capable of accurately detecting mutations even when plasma samples are used as the specimen....Notably, this product has an additional strength in its ability to detect Exon 20 Insertion..."
Non-US regulatory
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Droplex EGFR Mutation Test v2
1year
Gencurix signs a cancer diagnosis kit supply contract with Biotype (Gencurix Press Release)
"Gencurix announced...that it had signed a local agency supply contract with German Biotype...Gencurix plans to supply the Dropplex diagnostic kit, a digital PCR-based cancer companion diagnostic product, to Germany and other European countries through Biotype. Gencurix received European in vitro diagnostic medical device certification (CE-IVD) for six Dropplex products."
Licensing / partnership
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Droplex BRAF Mutation Test • Droplex EGFR Mutation Test v2 • Droplex KRAS Mutation Test • Droplex PIK3CA Mutation Test • Droplex POLE Mutation Test • Droplex c-Met Exon14 Skipping Test
1year
Gencurix, liquid biopsy and lung cancer companion diagnosis product approved by the Ministry of Food and Drug Safety (Gencurix Press Release)
"Gencurix...announced on the 7th that 'Dropplex EGFR Mutation Test V2' has obtained manufacturing permission from the Ministry of Food and Drug Safety...Gencurix's Dropplex EGFR Mutation Test V2 is a diagnostic kit product that enables patients to select the most suitable targeted therapy by detecting mutations in the EGFR test, which is the most basic and important test in the field of cancer companion diagnosis."
Non-US regulatory
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Droplex EGFR Mutation Test v2
2years
Gencurix acquires European certification for 6 types of cancer companion diagnosis 'Dropplex' (Gencurix Press Release)
"Gencurix...announced on the 21st that it has obtained European certification (CE) for 6 types of 'Dropplex', a molecular diagnostic (PCR)-based cancer companion diagnostic product...Dropplex consists of products that target a total of six biomarkers (biomarkers) including lung cancer (EGFR v2, c-MET), colorectal cancer (KRAS), endometrial cancer (POLE), breast cancer (PIK3CA) and thyroid cancer (BRAF)."
European regulatory
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Droplex BRAF Mutation Test • Droplex EGFR Mutation Test v2 • Droplex KRAS Mutation Test • Droplex PIK3CA Mutation Test • Droplex POLE Mutation Test • Droplex c-Met Exon14 Skipping Test
over2years
Gencurix acquires US patent for 'world's first digital PCR-based IVD' companion diagnostic kit (Gencurix Press Release)
"Gencurix...announced on the 25th that 'Composition for detecting epithelial cell growth factor receptor gene mutation and kit containing same' in the United States The patent has finally been obtained...The patent is about a method and kit composition for detecting EGFR mutations, which are mainly found in lung cancer patients. This was applied to 'Droplex EGFR Mutation Test (hereafter Dropplex EGFR), the world's first digital PCR-based IVD (medical device certification) product developed by Gencurix."
Patent
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Droplex EGFR Mutation Test v2